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AuthorisedTherapeutic exploratory (Phase II)Interventional

HOVON 168: Epcoritamab in Addition to R-Mini-CHOP Compared to R-Mini-CHOP in Elderly, Frail or Unfit Patients with Diffuse Large B-cell Lymphoma

Diffuse large B-cell lymphoma (DLBCL) is a fast-growing cancer of the white blood cells. Standard chemotherapy can be tough on the body, especially for older or less fit patients. Because of this, doctors often use a gentler, reduced-dose treatment called R-mini-CHOP. This Phase II clinical trial tests whether adding a newer targeted drug, called epcoritamab, to standard R-mini-CHOP works better than R-mini-CHOP alone. Epcoritamab is a specialised antibody designed to help the body's own immune system find and attack cancer cells. Doctors want to find out if this new combination can help more people get rid of all signs of their cancer (complete remission) and live longer without the disease returning. Researchers will also closely monitor safety, side effects, and how patients feel during their day-to-day lives throughout the study.

At a glance

Status
Authorised
Phase
Therapeutic exploratory (Phase II)
Sponsor
Hemato-Oncologie voor Volwassenen Nederland (Hovon) Stichting
Enrolment target
276
Start
31 Aug 2026

What is this study about?

Diffuse large B-cell lymphoma (DLBCL) is the most common type of high-grade non-Hodgkin lymphoma. It affects B-cells, which are white blood cells that normally help your body fight off infections. Standard treatments often involve strong chemotherapy. However, for people who are older or who have other health conditions, full-strength chemotherapy can cause severe side effects. In these cases, doctors often prescribe a lower-dose chemotherapy combination called R-mini-CHOP, which is easier to tolerate but may not always keep the cancer away for as long as hoped.

This trial is looking at whether adding a modern medicine called epcoritamab can improve treatment outcomes. Epcoritamab is a 'bispecific antibody'. It works like a bridge: one end attaches to the cancer cell, and the other end attaches to an immune cell. This brings the immune cell directly to the cancer cell to destroy it. Researchers hope that combining this targeted approach with gentler chemotherapy will give patients a better chance of clearing the cancer without overwhelming their bodies.

By taking part, patients help doctors understand whether this combined treatment is safe and effective for people who cannot have standard intensive therapy. The findings could change how older or frail individuals with this type of lymphoma are treated across the NHS and worldwide in the future.

Key takeaways

  • Tests a new drug called epcoritamab added to reduced-dose chemotherapy.
  • Aimed at older, frail, or less fit adults with diffuse large B-cell lymphoma.
  • Aims to achieve complete cancer remission and longer time free of disease.
  • Requires regular hospital visits for injections, drips, and health checks.
  • Participation is entirely voluntary, and you can leave at any time.

Who may be eligible?

This study is designed for adults who have been diagnosed with diffuse large B-cell lymphoma (DLBCL) and need treatment. It focuses specifically on individuals who are considered elderly, frail, or not fit enough to undergo full-dose intensive chemotherapy.

Both men and women of any age may be considered, provided they meet the medical criteria for being unable to have standard full-strength treatment. Your hospital doctor will carry out standard health checks to confirm whether this study is suitable for your general condition.

You might not be able to join if you have certain other serious medical conditions, such as severe heart or kidney problems, or active infections that could make the treatment unsafe. Your lymphoma specialist will review your full medical history to check if the trial is right for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. I have been diagnosed with diffuse large B-cell lymphoma (DLBCL).
  2. My doctor has advised that standard full-strength chemotherapy may be too harsh for me.
  3. I am able to travel to the hospital for regular treatment visits and check-ups.
  4. I am open to receiving treatment through injections or drips into a vein.
  5. I do not have severe, uncontrolled heart, liver, or kidney problems.
Answer every question to see your result.

What does participation involve?

If you take part, you will be assigned to a treatment group to receive either the standard reduced-dose chemotherapy (R-mini-CHOP) alone or R-mini-CHOP combined with the new drug, epcoritamab. Epcoritamab and MabThera (part of the chemotherapy mix) are given as injections or slow drips into a vein (infusions) at the hospital.

You will need to visit the hospital regularly during your treatment cycles for check-ups, blood tests, and scans (such as PET-CT scans) to see how the lymphoma is responding. The clinical team will also ask you to complete short questionnaires about your quality of life and how you are feeling.

Active treatment usually lasts several months. After your treatment ends, you will have regular follow-up appointments so the medical team can monitor your health, check for any late side effects, and make sure the cancer has not returned. Total participation time often spans a couple of years.

Potential risks and benefits

The possible benefit of taking part is that the treatment combination might control your lymphoma more effectively and keep you well for longer. However, there is no guarantee that it will work better than standard care. All cancer medicines carry a risk of side effects, including tiredness, an increased risk of infections, nausea, or immune reactions. Your study team will watch you closely and treat any problems quickly. Joining the trial is entirely your choice, and you can withdraw at any time without your regular NHS care being affected.

Locations (11)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
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    Unverified
    Czechia
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    Unverified
    Denmark
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    Unverified
    Croatia
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    Unverified
    Spain
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    Unverified
    Sweden
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    Unverified
    Finland
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    Unverified
    Portugal
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    Unverified
    Ireland
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    Unverified
    Netherlands
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    Unverified
    Belgium
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    Unverified
    Norway

Common questions

What is diffuse large B-cell lymphoma?

It is a fast-growing type of blood cancer that affects white blood cells called B-lymphocytes, which normally fight off infections.

What does R-mini-CHOP mean?

It is a gentler, reduced-dose version of a common chemotherapy combination designed for people who might struggle with full-strength treatment.

How is epcoritamab given?

It is given as an injection under the skin by a trained nurse or doctor during your hospital visits.

Do I have to pay to take part in this trial?

No. The trial medicines and tests are provided free of charge, though you should check if help is available for travel costs to extra visits.

Can I leave the study if I change my mind?

Yes, you can leave the study at any point. Deciding to stop will not affect the standard of NHS care you receive.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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